A Phase III, Open-label, Uncontrolled, Multicentre, Rollover Study to Assess Safety and Efficacy of LB03002 Administered Weekly in Adults With Growth Hormone Deficiency
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 主要终点
- Incidence of adverse events, antibody formation and local tolerability assessment after 1 year treatment from baseline of BPLG-005
研究概览
简要总结
The objective of this rollover study is to evaluate the long term (1 year) safety of a new weekly administered growth hormone preparation in adults with growth hormone deficiency who were treated with the same experimental preparation in study BPLG-005. In addition, further change in efficacy endpoints of BPLG-005 by prolonged treatment will be evaluated. Additional efficacy and safety data of the experimental preparation will be obtained from the switch-over patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 23 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (male and female) who have completed the Visit 8 of preceding main study (BPLG-005) and are willing to continue their participation in an extension study
- •If female, women of child-bearing potential who are using a reliable method of contraception and be willing to use it throughout the study. A negative urine pregnancy test at Visit 0 is required for females of child-bearing potential
- •Written informed consent of the patient
排除标准
- •Evidence of active malignancy or growth of a previously stable tumor
- •Benign intracranial hypertension
- •Clinically significant respiratory, cardiac, hepatic, renal, neuromuscular disease
- •Non-compliance with medications, un-cooperativeness or drug abuse during the BPLG-005 study
- •Patients who are not able to comply with the study protocol for any reason
研究组 & 干预措施
LB03002 throughout
administered LB03002 for preceding 26 weeks
干预措施: Growth hormone - LB03002 (Drug)
Switched to LB03002
administered placebo for preceding 26 weeks
干预措施: Growth hormone - LB03002 (Drug)
结局指标
主要结局
Incidence of adverse events, antibody formation and local tolerability assessment after 1 year treatment from baseline of BPLG-005
时间窗: 1 year
次要结局
未报告次要终点